MAUDE Adverse Event Report: LIVANOVA USA INC CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned cannula was inspected, and the luer connector that is intended to be attached to the end of the needle, was found to not adhering and was loose in the return bag.The needle was placed in the luer connector and found the needle fit loosely in the luer suggesting the bonding compound applied to this connection was not sufficient to retain the trocar needle in the connector.A review of the dhr did not identify any deviation, non-conformity or material issue relevant to the reported failure.Livanova investigation clarified that the disconnection was ascribable to an operator error while distributing of adhesive between connector and trocar (needle).As a part of continuous improvement project, in september 2019 the standard operating procedure for the manufacturing of the complained cannula has been revised including additional check for first piece in curing trocar to luer bond and additional 100% inspection of adhesive cure for trocar to luer bond with needle to test for softness.Manufacturing personnel has been trained on the new revision of the procedure on september 17th, 2019.Livanova is committed to identify possible corrective actions in the manufacturing process aimed to reduce/eliminate this potential human error.Livanova will keep monitoring the market for similar events.
Additional Manufacturer Narrative
Patient information were not provided a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been received at livanova usa inc for investigation.Investigation is ongoing.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has been informed that, during a procedure, the cap that helps to extract the metal needle inside the aortic root cannula detaches from the metal needle.There is not report of any patient injury.

• Brand Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9201244
• Report Number: 1718850-2019-00019
• Device Sequence Number: 409196
• Product Code: DWF
• UDI-Device Identifier: 00803622103001
• UDI-Public: (01)00803622103001(240)AR-11012(17)220430(10)1911400034
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11012
• Device Lot Number: 1911400034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1